European Medicines Agency Seeks ‘Harmonized Approach’ to Clinical Trials Addressing COVID-19 in the EU

Mar 20, 2020 | Clinical Trials, Coronavirus, COVID-19, European Medicines Agency, Regulatory

European Medicines Agency Seeks ‘Harmonized Approach’ to Clinical Trials Addressing COVID-19 in the EU

Has European research into a COVID-19 treatment been too fragmented? Apparently, the European Medicines Committee (CHMP or EMA) thinks so based on a recent statement meant for investigation there. The overarching regulatory authority now promotes a “harmonized approach” for data collection as well as common framework for COVID-19 clinical trials across the European Union (EU). The governing body seeks the efficiencies yielded from scale not to mention inclusiveness. Will it work?

Core Emphasis

CHMP suggests larger, multi-arm clinical trials covering a number of agents in parallel as to yield more and better actionable data. And they seek that all EU countries are considered for inclusion in these trials. More coordination, coverage across the EU, and ensuring a diversified population of participants drives the agency’s official statement.

Enough Data?

A number of small regional studies and compassionate use programs unfold in Europe around certain research and development clusters—in places and spaces that have heavy concentrations of basic research. In many cases, reports the CHMP, these studies involve only a handful of participants and it may not be sufficient to produce the aggregate data required for drug development.

Supporting the Crisis

The European Medicines Agency has prepared to marshal resources and expedite process where and when it can to support investigations into COVID-19 treatments and vaccines. As TrialSite News reported on the U.S. Food and Drug Administration (FDA) recent COVID-19 clinical trial guidance, the EMA too understands the clinical investigations in Europe will be disrupted by the pandemic. For example, protocol modification may be inevitable for many depending on a number of factors from trial design and nature of the disease under study to adjustments of how patients actually communicate with medical professionals (e.g. support alternative channels).


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